Examining the Change in Microbiome Diversity and Urine Metabolites After Lignite Extract Use

Microbiome Clinical Trial

Official title:

Examining the Change in Microbiome Diversity and Urine Metabolites After Lignite Extract Use

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03026621
• Other study ID #: 104
• Status: Recruiting
• Phase: N/A
• First received: January 17, 2017
• Last updated: January 17, 2017
• Start date: January 2017
• Est. completion date: March 2017

Study information

• Verified date: January 2017
• Source: Seraphic Group Inc
• Contact: David Roberts, MPH
• Phone: 844 432-5488
• Email: droberts[@]seraphicgroup.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether or not 'Restore' lignite extract mineral supplement impacts the microbiome composition of the mouth and gut. Additionally, participant urine samples will be examined to determine whether or not 'Restore' mineral supplement impacts the composition urine biomarkers and toxins.

Description:

OBJECTIVES:

The purpose of this study is to determine whether or not 'Restore' lignite extract mineral supplement impacts the microbiome composition of the mouth and gut. Additionally, participant urine samples will be examined to determine whether or not 'Restore' mineral supplement impacts the composition urine biomarkers and toxins.

BACKGROUND & RATIONALE There is mounting evidence that the composition of the microbiome can change quickly. Unpublished case reports have shown significant shifts in the microbiome when participant's diet changes from a high carbohydrate to a high fat diet. Clinically, the use of 'Restore' mineral supplement has led to the bulking of stool in people using it for the first time within one or two days of first dose, further indicating a change in the gut microbiome.

Given these observations, this clinical trial was designed to examine how taking 'Restore' mineral supplement may impact the microbiome by examining the gut bacteria composition at two days, and again at two weeks. Our hypothesis is that taking Restore alone can lead to a quantifiable shift in the diversity of the microbiome as measured by the Simpson's Diversity Index, a mathematical measure of species diversity in a community. This index provides more information about community composition than simply species richness by also taking into account the relative abundances of different species.

There is also evidence that Restore mineral supplement can impact urine composition. Specifically, we will be examining the change in the presence of zonulin, glyphosate, creatinine-albumin ratio, and stem cells.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• People over 18 and under 80 who have never taken Restore gut supplement

Exclusion Criteria:,

• pregnant women, prisoners, people with primary bowel disorder or who have taken antibiotics over the last four weeks

Related Conditions & MeSH terms

• Microbiome

Intervention

Dietary Supplement:
• Lignite Extract
The study design is a double-blind case-control trial, whereby half of the participants will be "cases" and will be asked to take 5mL 'Restore' mineral supplement three times each day. The other half of the participants will be "controls" and will be asked to take 5mL of a placebo three times each day. Both the study leader and the participants will be blinded to who receives Restore and who receive placebo.

Other:
• Herbal tea
This is an herbal tea that will look like the control

Locations

Country	Name	City	State
United States	Biomic Sciences	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Seraphic Group Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal Microbiome	Next generation genetic sequence will be taken	2 weeks
Secondary	Oral Microbiome	Next generation genetic sequence will be taken	2 weeks
Secondary	Urine metabolies	Urine glyphosate, CD34, zonulin, creatine-albumin ratio and a urine analysis panel	2 weeks